ISO 13485:2016 Overview

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. Estimated to take up to four-hours to complete, this ISO 13485 overview is an overview.

What Will You Learn

By participating in this online course, you will understand:
  • The high level requirements and intent of this international standard
  • The methods to managing an organization’s QMS in compliance with ISO 13485:2016
  • How the requirements can be interpreted/should be implemented within an organization

Course Information

COURSE LENGTH
4.00 Hours
ACCESS PERIOD
365 Days

Is This Course For You

This course is for you if you want to:
  • Quickly and efficiently understand the higher level requirements for top management
  • Improve your curriculum vitae and career opportunities with qualifications in ISO 13485:2016
  • Upgrade your internal auditing expertise from ISO 13485:2003 or ISO 9001:2018 to ISO 13485:2016
  • Train top management economically and without the added cost of travel

Find answers to FAQs.

Materials Provided

  • 365 days of online single-user access (from date of purchase) to the approximately 4 hours of instruction
  • Continuous assessment to check knowledge and application of key concepts
  • Follow-up to your content questions

Course Requirements

  • Windows or macOS
  • Microsoft Edge, Mozilla Firefox, Google Chrome, Safari (Other OSs and browsers including mobile devices are not supported by may work)
  • Broadband-1Mbps minimum

Topics

  • General Requirements of ISO 13485:2016
    • Section 4. General and Documentation Requirements
    • Section 5. Management Responsibility
    • Section 6. Resource Planning
    • Section 8. Measurement, Analysis, and Improvement

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